FDA applicant

Pacesetter, Inc.

Sylmar, CA8 decisions1995–19980 recalls

FDA records 8 decisions for Pacesetter, Inc. (Sylmar, CA) from 1995 to 1998: 8 510(k) clearances. Most are in product codes DTB (Permanent Pacemaker Electrode) and CAF (Nebulizer (Direct Patient Interface)). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Pacesetter, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pacesetter, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pacesetter, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Pacesetter”

FDA records each applicant name separately; these may or may not be the same firm.

Pacesetter Systems 98

Pacesetter, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Pacesetter”